BECOME CHILDREN OF HOLDERS Corpus Callosum Agenesis Screened IN PERIOD Antenatal

NCT ID: NCT02826824

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-09-30

Brief Summary

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The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. This malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.

Several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. These, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases Similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum Although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.

Detailed Description

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Conditions

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Corpus Callosum Agenesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children born between January 2000 and January 2013 carrying a corpus callosum agenesis detected prenatally via the multidisciplinary center for prenatal diagnosis (CPDPN) of the Alsace-Lorraine region,
* Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

Exclusion Criteria

* Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes
Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent LAUGEL, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

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Service de Pediatrie 1 - Hopital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent LAUGEL, MD, PhD

Role: CONTACT

33 (0)3.88.12.84.98

Eléonore FEUGEAS, MD

Role: CONTACT

33 (0)3.88.12.84.98

Facility Contacts

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Vincent LAUGEL, MD, PhD

Role: primary

33 (0)3.88.12.84.98

Eléonore FEUGEAS, MD

Role: backup

33 (0)3.88.12.84.98

Other Identifiers

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6268

Identifier Type: -

Identifier Source: org_study_id

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